Genomic Health and Epic Sciences Announce Strategic Collaboration to Deliver Novel AR-V7 Liquid Biopsy Test to Predict Treatment Response in Metastatic Prostate Cancer

Print 07 July 2016

Validation Study Led by Memorial Sloan Kettering Cancer Center, Published in JAMA Oncology, Demonstrated Patients with AR-V7 Positive Circulating Tumor Cells Have Significantly Better Outcomes if Treated with Chemotherapy versus Hormonal Treatments

REDWOOD CITY, Calif. and SAN DIEGO, July 7, 2016 /PRNewswire/ -- Genomic Health, Inc. (GHDX) and Epic Sciences, Inc. today announced an exclusive agreement to commercialize Epic Sciences' novel AR-V7 liquid biopsy test in the United States through Genomic Health's world-class commercial channel. The blood-based test detects the V7 variant of the androgen receptor protein (AR-V7) in the nucleus of circulating tumor cells (CTC) – information that can help guide treatment selection in patients with metastatic castration-resistant prostate cancer (mCRPC).

AR-V7 expression has been associated with resistance to hormone therapy drugs called androgen receptor signaling (ARS) inhibitors. A recently published study in JAMA Oncology from Memorial Sloan Kettering Cancer Center demonstrated that mCRPC patients with AR-V7 positive CTCs had significantly better clinical outcomes when treated with taxane chemotherapy, which suggests that patients with detectable blood levels of AR-V7 should consider life prolonging chemotherapy as an alternative to potentially less effective and more expensive hormonal treatment with ARS drugs. These study results underscore the potential for an AR-V7 predictive test to allow advanced prostate cancer patients to avoid ineffective therapies and to receive chemotherapy at an earlier stage when it may be more beneficial.

"The validation study published in JAMA Oncology demonstrated that patients with AR-V7 positive CTCs have longer survival on taxane chemotherapy relative to those on AR signaling inhibitors," said Dr. Howard Scher, M.D., study principal investigator and chief of Genitourinary Service at Memorial Sloan Kettering Cancer Center, New York. "The growing body of evidence for the clinical utility of AR-V7 supports its use in clinical practice as a treatment-specific biomarker to guide treatment selection for patients with advanced prostate cancer."

Virtually all men with metastatic prostate cancer eventually develop mCRPC, an advanced stage of the disease where the standard of care includes abiraterone, enzalutamide and taxanes. It is estimated that each year, about 50,000 mCRPC patients could benefit from knowing their AR-V7 status prior to selecting further treatment. With the use of this new test, the two companies estimate substantial healthcare savings per patient tested by tailoring treatment selection.

"Epic Sciences' no cell left behind® platform offers the highest clinical sensitivity and specificity for nuclear AR-V7 characterization. This enables a best-in-class test that provides clinically actionable information that can directly affect patient outcomes and health economics," said Murali Prahalad, president and chief executive officer, Epic Sciences. "The Epic Sciences AR-V7 test is the first of many groundbreaking tests we are developing, and our collaboration with Genomic Health is an important milestone to realize its commercial potential with a world-class partner."   

"This strategic collaboration allows us to leverage our successful commercial channel while continuing to generate growth across our business," said Frederic Pla, Ph.D., chief business and product development officer, Genomic Health. "Epic Sciences' industry leading CTC-based platform enables the delivery of clinically actionable information to prostate cancer patients at a critical treatment decision point. Offered as part of our Oncotype IQ™ Genomic Intelligence Platform that collectively assesses DNA, RNA, and protein using either PCR, NGS, or image-based analysis, Epic Sciences' AR-V7 test will complement our expanding portfolio, which also includes Oncotype SEQ™, our recently launched liquid biopsy mutation panel."

Based on the agreement, Genomic Health will have exclusive distribution rights to market and sell the new Epic Sciences liquid biopsy test in the U.S. beginning in early 2017. The test will be offered through Genomic Health's commercial channel to enable physicians to order the test and view the results through the current physician portal. The test will be performed by Epic Sciences at its centralized, CLIA-certified laboratory in San Diego, Calif. 

As part of the agreement, Genomic Health will make an equity investment in Epic Sciences. Further financial terms will not be disclosed at this time. 

About Genomic Health 
Genomic Health, Inc. (GHDX) is the world's leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of cancer, one of the greatest issues in healthcare today. With its Oncotype IQ™ Genomic Intelligence Platform, the company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of clinical and genomic big data into actionable results for treatment planning throughout the cancer patient journey, from diagnosis to treatment selection and monitoring. The Oncotype IQ portfolio of genomic tests and services currently consists of the company's flagship line of Oncotype DX gene expression tests that have been used to guide treatment decisions for more than 600,000 cancer patients worldwide. Genomic Health is expanding its test portfolio to include additional liquid and tissue-based tests. The company is based in Redwood City, California, with international headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com.

About Epic Sciences
Epic Sciences, Inc. is developing novel diagnostics to personalize and advance the treatment and management of cancer. Epic Sciences' mission is to enable the rapid and non-invasive detection of genetic and molecular changes in cancer throughout a patient's journey. The company was founded on a powerful platform to identify and characterize rare cells, including circulating tumor cells (CTCs). Epic Sciences' no cell left behind® technology helps match patients to targeted therapies and monitor for drug resistance, so that the best treatment path can be chosen at every clinical decision point. Today, we partner with leading pharmaceutical companies and major cancer centers around the world. Epic Sciences' goal is to commercialize our technology to increase the success rate of cancer drugs in clinical trials and improve patient outcomes by providing physicians real-time information to guide treatment choices. Further information is available on the Company's website, www.epicsciences.com. 

This press release contains forward-looking statements about Genomic Health, Inc. within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to Genomic Health's: business model; the regulation of Genomic Health's tests or any tests offered through its commercial channel; the applicability of clinical study results to actual outcomes; Genomic Health's ability to develop, commercialize or collaborate to offer any new tests in new markets domestically and internationally; the risk that sufficient levels of reimbursement may not be obtained or maintained, domestically or abroad, for Genomic Health's tests or tests offered through its commercial channel; competition; unanticipated costs or delays in research and development efforts; Genomic Health's ability or the ability of its collaborators to obtain capital when needed to support the activities contemplated by the collaboration; and the other risks and uncertainties set forth in Genomic Health's filings with the Securities and Exchange Commission, including the risks set forth in Genomic Health's Quarterly Report on Form 10-Q for the quarter ended March 31, 2016. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

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